BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16 LEAD, 60 CM

    MDR report key: 6663320 · Received June 23, 2017

    Report

    Report Number
    1627487-2017-03370
    Event Type
    Injury
    Date Received
    June 23, 2017
    Date of Event
    April 13, 2017
    Report Date
    August 25, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A MOTOR VEHICLE ACCIDENT THE PATIENT EXPERIENCED INEFFECTIVE AND UNCOMFORTABLE STIMULATION (DESCRIBED AS SHOCKS AND ZAPS). REPROGRAMMING WAS TRIED WHICH RESOLVED THE ISSUES. HOWEVER, SYSTEM DIAGNOSTICS REVEALED MULTIPLE HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE STIMULATION WAS RESTORED, HENCE THE ISSUE RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2017 WHEREIN THE IPG WAS REPOSITIONED (REFERENCE MFR. REPORT# 1627487-2017-03462-001). NO INTERVENTION WAS TAKEN AGAINST THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445591 LAMITRODE TRIPOLE 16 LEAD, 60 CM SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 5164217

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other MODEL 3662, SCS IPG